Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion
FDA device recall Z-3106-2011 · posted 2011-08-31 · Terminated
Recall details
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Reason for recall
- Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head.
- Action taken
- Depuy Mitek issued Original Customer Notification Letter on 6/27/11 and an Updated letter to clarify the lot number information sent 6/29/11. Hospitals requested to immediately check all inventories for affected product and return for repalcement product. Also notify surgeons aware of this potential issue and potential risk of a delay in surgery. questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-800-382-4682, PROMPT 3.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 75 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2011-06-27
- Date posted
- 2011-08-31
- Date terminated
- 2012-01-19
- Location
- Raynham, MA
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